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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceIMPELLA 2.5 System
Generic NameTemporary non-roller type left heart support blood pump
ApplicantAbiomed, Inc.
22 Cherry Hill Dr.
Danvers, MA 01923
PMA NumberP140003
Date Received03/18/2014
Decision Date03/23/2015
Product Code OZD 
Docket Number 25M-1177
Notice Date 04/10/2015
Advisory Committee Cardiovascular
Clinical TrialsNCT00534859
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE IMPELLA. THIS DEVICE IS INDICATED FOR:THE IMPELLA 2.5 SYSTEM IS A TEMPORARY (<= 6 HOURS) VENTRICULAR SUPPORT DEVICE INDICATED FOR USE DURING HIGH RISK PERCUTANEOUS CORONARY INTERVENTIONS (PCI) PERFORMED IN ELECTIVE OR URGENT, HEMODYNAMICALLY STABLE PATIENTS WITH SEVERE CORONARY ARTERY DISEASE AND DEPRESSED LEFT VENTRICULAR EJECTION FRACTION, WHEN A HEART TEAM, INCLUDING A CARDIAC SURGEON, HAS DETERMINED HIGH RISK PCI IS THE APPROPRIATE THERAPEUTIC OPTION. USE OF THE IMPELLA 2.5 IN THESE PATIENTS MAY PREVENT HEMODYNAMIC INSTABILITY WHICH CAN RESULT FROM REPEAT EPISODES OF REVERSIBLE MYOCARDIAL ISCHEMIA THAT OCCUR DURING PLANNED TEMPORARY CORONARY OCCLUSIONS AND MAY REDUCE PERI- AND POST-PROCEDURAL ADVERSE EVENTS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S007 S013 S016 S012 S021 S022 S003 S004 S005 
S006 S017 S018 S014 S015 S008 S009 S010 S011 S019 S020 S048 
S049 S032 S033 S034 S035 S036 S025 S026 S027 S071 S072 S073 
S037 S038 S039 S056 S075 S064 S065 S066 S052 S053 S054 S055 
S102 S103 S099 S100 S101 S084 S085 S086 S087 S088 S109 S110 
S091 S081 S082 S083 S106 S107 S121 S122 S126 S127 S116 S117 
S129 S130 S131 S118 S028 S029 S030 S031 S023 S024 S042 S043 
S040 S057 S058 S059 S061 S062 S063 S068 S069 S070 S076 S077 
S050 S051 S044 S045 S046 S047 S074 S095 S089 S113 S080 S105 
S078 S079 S111 S112 S096 S097 S098 S092 S093 S094 S123 S124 
S128 S135 S136 S119 S125 S115 S137 S138 
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